Product Risk Manager

Job Title

Product Risk Manager

Job Description

The Product Risk Manager is responsible for leading a cross-functional team, overseeing risk management activities during product development, being accountable for post market risk assessments, providing business-level guidance on product safety and implementing risk assessment methodologies. The role handles product risk management inquiries, participates in investigations and communicates risk assessments and recommendations to senior risk management for informed decision-making. The role fosters growth and effectiveness within the product risk management team and Ensures product risks associated with development activities are appropriately identified, evaluated, controlled, and documented. The role develops and maintains comprehensive documentation of risk management processes and procedures for reference and compliance purposes. The role requires minimum oversight of senior risk manager.

Job Responsibilities

• Manages the product development cross-functional team responsible for creating and/or approving all risk management deliverables for one complex or multiple simple products throughout its' lifecycle.
• Provides business-level guidance on product hazards and harms and collaborates with medical affairs to ensure identification of harms and alignment with applicable regulations and standards, aiming to mitigate risks and safeguard patient, user and consumer safety.
• Participates in process improvement initiatives to enhance efficiency and effectiveness in risk management, striving for best-in-class practices by identifying and implementing enhancements that streamline processes and improve overall performance in managing and mitigating risks.
• Manages one or more junior team members in product risk management, guides their development, ensures adherence to risk management practices, and coordinates their efforts to support effective risk assessment and mitigation across product lines.
• Monitors key performance indicators (KPIs) pertaining to product risk management processes, assisting senior risk managers in facilitating informed decision-making and strategic planning within the department to ensure optimal performance and compliance with regulatory standards.
• Monitors and maintains vigilant oversight of regulatory and standard requirements and implements necessary measures to uphold safety standards to ensure compliance with product safety regulations and standards.
• Accountable for low-to-high complexity product risk management inquiries, participates in teams conducting investigations, and effectively communicates risk findings and recommendations to senior risk management for informed decision-making and ensures proactive risk mitigation strategies are developed to maintain patient, user and consumer safety.
• Implements effective risk assessment methodologies to comprehensively evaluate potential hazards associated with products, facilitating informed decision-making and proactive mitigation strategies.
• Ensures the proactive identification, analysis, and mitigation of potential risks associated with product development, deployment, and lifecycle management, thereby safeguarding organizational objectives and optimizing outcomes.

Minimum required Education: Bachelor's/Master's Degree in Medical Sciences, Engineering, Life or Physical Science, Computer Science/Software development or equivalent.

Minimum required Experience: Minimum 2 years of experience with Bachelor's OR Minimum 1 years of experience with Master's in areas such as Medical Device Product Development, Post Market Surveillance, Quality Engineering or equivalent.

Preferred Skills

• Post-Market Surveillance Mechanisms
• Health and Safety Monitoring
• Quality Management Systems (QMS)
• Quality Specifications
• CAPA Methodologies
• Continuous Improvement
• Budget Management
• People Management
• KPI Management
• Regulatory Compliance
• Quality Risk Management
• Reliability Engineering
• Product Risk Management
• Business Acumen